Trial document




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  DRKS00004807

Trial Description

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Title

The effect of liftfree mobilization on the pulmonary ability and quality of life among patients suffering from COPD level III-IV

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

There will be a pilot study with approximately 22 patients suffering from a chronic lung dis-ease (COPD). Patients suffering from these diseases COPD report about an improving pulmonary capacity and an improving quality of life in the course of their treatment with physiotherapeutic, mobilizing therapeutic treatment (liftfree mobilization) of the mobility of the thorax. This statement has not been verified yet. The purpose of this pilot study aims in testing the effect of this treatment with patients suffering from COPD level III-IV with regard to changes in terms of quality of life and pulmonary ability. The recruitment of the patients during the course of the residential stay in hospital will take place in the Hufeland-Klinik in Bad Ems. According to medical prescription all participating patients receive the same basic physiotherapeutic treatment. Additionally, all participating patients receive 10 additional treatments with “liftfree mobilization” of the mobility thorax/thoracic spine/ribs from of the concept on “Functional Kinetics”. All those patients from the control group additionally receive a total treatment of 10 therapeutic ultrasonic with a switched-off ultrasonic test instrument.

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Brief Summary in Scientific Language

The chronic obstructive pulmonary disease (COPD) is nowadays regarded as a widespread disease. Globally the world this disease concerns about 44 million people. In Germany, it is one of the most frequent chronic diseases for adults, the prevalence rate among 40-year-old people is 8.7% and among 70-year-old people it is 19%. COPD is ranked 7th of all causes of death, until 2020 it will be ranked 3rd of all causes of death. However, there are only few studies, which deal with the effect of physiotherapeutic interventions for this disease pattern. Patients suffering from these diseases COPD report about an improving pulmonary capacity and an improving quality of life in the course of their treatment with physio-therapeutic, mobilizing therapeutic treatment (liftfree mobilization) of the mobility of the thorax. This statement has not been verified yet. In the course of the pilot study presented, the effect of the treatment of the liftfree mobilization on patients suffering from COPD level III-IV will be tested with regard to changes in terms of the quality of life and in terms of the pulmonary ability.

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Organizational Data

  •   DRKS00004807
  •   2013/03/12
  •   [---]*
  •   yes
  •   Approved
  •   2013-01, Ethikkommission des Deutschen Verbandes für Physiotherapie Physio-Akademie gGmbH
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Secondary IDs

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Health Condition or Problem studied

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
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Interventions/Observational Groups

  •   In the course of their 4-weeks stay in hospital patients receive 10 treatments altogether (2-3 treatments per week with a treatment of 30 minutes each) including therapeutical treatment of liftfree mobilization in order to mobilize locomotor system thorax, ribs and thoracic spine in Flexion/Extension, Lateralflexion and Rotation.
  •   Patients suffering from COPD III-IV: In the course of their 4-weeks stay in hospital those patients from the control group will additionally receive a total treatment of 10 therapeutic ultrasonic (twice/three times per week with a treatment of 30 minutes each) with a switched-off ultrasonic test instrument.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of pulmonary data: FEV 1 (forced expiratory volume), FEV 1% VC (vital capacity) and TLC (total lung capacity) via pulmonary diagnostics prior to the study and after having received 10 singular treatments.

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Secondary Outcome

Questions concerning the quality of life, collected prior to the study and after 4 weeks and after having received 10 singular treatments via questionnaire: EORTC QLQ-C 30

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/03/11
  •   22
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   70   Years
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Additional Inclusion Criteria

Criterion for inclusion: COPD III-IV (GOLD); sex:m/w; none-smoker (for more than 6 months); age: 50-70 years; BMI: <30

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Exclusion Criteria

Criterion for exclusion: maligne tumore; chemotherapy/radiation therapy for the previous 12 months; smoker; transplantation of lungs; acute excacerbation; acute fractures; psycho-logical disease; cardiac pacemaker; neurological disease.

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Addresses

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    • Praxis für Physiotherapie
    • Mr.  Markus  Oehl 
    • Stegemannstr. 44
    • 56068  Koblenz
    • Germany
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    • Praxis für Physiotherapie
    • Mr.  Markus  Oehl 
    • Stegemannstr. 44
    • 56068  Koblenz
    • Germany
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    • Praxis für Physiotherapie
    • Mr.  Markus  Oehl 
    • Stegemannstr. 44
    • 56068  Koblenz
    • Germany
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Sources of Monetary or Material Support

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    • Praxis für Physiotherapie
    • Mr.  Markus  Oehl 
    • Stegemannstr. 44
    • 56068  Koblenz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/30
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Trial Publications, Results and other Documents

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